TY  - BOOK
ED  - DYADEM.
TI  - Guidelines for failure mode and effects analysis for medical devices /  
SN  - 0849319102
PY  - 2003///
CY  - Boca Ratón : 
PB  - DYADEM, 
KW  - DISPOSITIVOS MEDICOS
KW  - MODOS DE FALLA
KW  - ANALISIS DE EFECTOS
KW  - CONTROL DE CALIDAD
KW  - SEGURIDAD
N2  - Introduction - Regulations and standards governing medical device manufacturing - Risk analysis methodologies - Overview of FMEA - FMEA procedures - FMEA team - Pitfalls with FMEA - Common tools used with FMEA - Product life cycle and FMEA - Product/design FMEA - Process FMEA - Application FMEA - Service FMEA - Post FMEA study - Control plans - Overview of failure mode, effects and criticality analysis (FMCA)
ER  -